FDA food-safety plan lacks clear direction: GAO

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Following a string of tainted-food scares, FDA, which is responsible for overseeing about 80% of the food supply, released a food-protection plan in November -- but the agency has since added few details about implementation, according to the Government Accountability Office.
The FDA provided GAO a draft work plan this month, but vagueness remains, according to testimony from GAO's Lisa Shames, natural resources and environment director.
"While this draft work plan provides more information on the action steps and deliverables to achieve the core elements, we continue to have concerns about FDA's lack of specificity on the necessary resources and strategies to fully implement the plan," according to Shames's testimony.
On Thursday, the House Energy and Commerce's oversight and investigations subcommittee is hearing from Shames and other witnesses, including Dr. David Acheson, the FDA's food safety czar, about the FDA's food-protection plan. As reports about tainted tomatoes are making headlines, there's concern that American lives are still at risk.
It's unclear how much money FDA will need for its food protection plan, but the price tag could be significant, according to GAO.
"While the work plan provides some basic information, more specific information, such as estimated resources needed to implement the various strategies -- the core elements, goals, and deliverables -- as well as the overall plan and timeframes for implementing the strategies, are needed to assess FDA's progress in implementing the plan or in acquiring the resources and authorities it needs," Shames said.
The GAO said if the FDA were to inspect every domestic and foreign food facility is would cost:

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A total of about $524 million to inspect each of the 65,500 domestic food firms regulated by FDA one time. That total assumes a cost of $8,000 for a domestic food safety inspection.
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A total of $3.16 billion to inspect each of the 189,000 registered foreign facilities one time. That total assumes a cost of $16,700 per inspection.

"These figures underscore the need for FDA to focus safety inspections based on risk," Shames said.
Targeted response
Overall, the FDA's proposal to focus inspections based on risk could be an efficient and effective approach, GAO said, especially given that the agency's inspections have not kept pace with the growth of firms in recent years. Between 2001 and 2007, the number of domestic firms under FDA's jurisdiction increased from about 51,000 to more than 65,500. Meanwhile, the number of these firms inspected declined from 14,721 to 14,566, according to GAO.
"FDA also reported declines in the number of inspections at overseas firms between 2001 and 2007 -- even as the United States has imported hundreds of thousands of different food products from tens of thousands of foreign food firms in more than 150 countries," according to Shames.
The report added that FDA has implemented few of GAO's recommendations to improve food-safety oversight in recent years.
"In light of the federal government's long-term fiscal challenges, agencies, including FDA, need to seek out opportunities to better leverage their resources," Shames said. "We have made 13 recommendations to help FDA better leverage its resources since 2004, and FDA has implemented four of them."
FDA has been late in issuing a progress report on actions taken to implement the food protection plan, according to GAO.
"Instead, FDA officials provided us with a broad overview of FDA's actions and, subsequently, provided us with a list of accomplishments drawn out of numerous public documents," Shames said. "We have noted that public reporting is the means through which the federal government communicates the results of its work to the Congress and the American people. Such reporting is in the public interest and promotes transparency in government operations." End of Story
Ruth Mantell is a MarketWatch reporter based in Washington.